| ISO 27185 First edition 2012-02-15 Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements |
| Recognition Date | 2016-06-15 |
| Recognition List | 042 |
| Recognition Number | 3-132 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Cardiovascular |
| FDA Tech | Robert T. Kazmierski FDA/OMPT/CDRH/ODE/DCD/IEDB/ 301-796-5447 Robert.Kazmierski@fda.hhs.gov |
.stds { color: #000000; float: center; width: 950px; margin: 0px 25px 0px 0px; } .stds-middle { color: #000000; float: center; width: 575px; margin: 0px 50px 50px 50px; } /* .stds-left { float: left; margin: 9px 30px 0px 0; } */ .stds-left { color: #000000; float: left; width: 700px; margin: 9px 0px 0px 0px; } .stds-search-left { float: left; width: 610px; margin: 9px 30px 0px 0; } .stds-search-right { float: right; width: 190px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f9f9f3; border: 1px solid #b0b0b0; -webkit-border-radius: 6px; -moz-border-radius: 6px; border-radius: 6px; } .stds-right { color: #000000; float: right; width: 170px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; } .stds-intro { margin: 0px 0px 18px 0px; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #stds_nr-form { margin-top: 18px; padding-top: 12px; border-top: 1px dashed #b0b0b0; } #stds-form { table-layout:fixed; width: 700px; font-size: 11px; border: 1px solid #b0b0b0; background-color: #f9f9f3; } #stds-form-title{ padding: 3px 3px 3px 3px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #stds-form-title-left { font-size: 13px; font-weight:normal; } #stds-form-title-right { /*float: right;*/ font-size: 11px; padding: 0px 0px 0px 500px; } #stds-form-results-right { /*float: right;*/ font-size: 11px; padding: 0px 0px 0px 600px; } #stds-search { height: 18px; margin: 0px; padding: 3px 10px; border: 1px solid #b0b0b0; font-size: 12px; color: #484138; } #stds-search:focus, #stds-search:hover { -webkit-box-shadow: 0 0px 6px rgba(0,0,0,.1); -moz-box-shadow: 0 0px 6px rgba(0,0,0,.1); box-shadow: 0 0px 6px rgba(0,0,0,.1); } #stds-results-number { margin-bottom: 12px; font-size: 10px; font-weight: bold; } #stds-results-table { margin-left:auto; margin-right:auto; text-align:left; padding: 0; border-collapse:collapse; table-layout:fixed; background-color: #f9f9f3; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #stds-results-table th { padding: 6px 12px; background-color: #f9f9f3; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #stds-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #stds-results-table tr:nth-child(odd) { /* background-color: #f3f3f3; */ } .sort { float: right; margin: 0px 10px 0px 0px; padding: 0px 5px 5px 5px; } /* .sort { float: right; margin-top: 5px;} */ .sort a { color: #484138; } .sort a:hover { color: #0f2a8c; } Recognized Consensus Standards // Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Recognized Consensus Standards var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: unescape('mp_js_orgin_url'), init: function(){ if (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, getCookie: function(name){ var start=document.cookie.indexOf(name+'='); if(start < 0) return null; start=start+name.length+1; var end=document.cookie.indexOf(';', start); if(end < 0) end=document.cookie.length; while (document.cookie.charAt(start)==' '){ start++; } return unescape(document.cookie.substring(start,end)); }, setCookie: function(name,value,path,domain){ var cookie=name+'='+escape(value); if(path)cookie+='; path='+path; if(domain)cookie+='; domain='+domain; var now=new Date(); now.setTime(now.getTime()+1000*60*60*24*365); cookie+='; expires='+now.toUTCString(); document.cookie=cookie; }, switchLanguage: function(lang){ if(lang!=MP.SrcLang){ var script=document.createElement('SCRIPT'); script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); document.body.appendChild(script); } else if(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ var script=document.createElement('SCRIPT'); script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); document.body.appendChild(script); } return false; }, switchToLang: function(url) { window.top.location.href=url; } }; var addthis_config = {data_track_clickback: true, ui_508_compliant: true, services_compact: 'facebook, twitter, linkedin, pinterest_share, email', services_exclude: 'print', image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
ISO 27185:2011 specifies requirements for the use of symbols conveying information on the safe and effective use of cardiac rhythm management medical devices. A listing is given of existing symbols that comply with the requirements of ISO 27185:2011.
ISO 27185:2011 is applicable to, and limited to, symbols for cardiac rhythm management medical devices that can be marketed globally. These symbols can be used on the devices themselves or their labelling.
| Regulation Number | Device Name | Device Class | Product Code |
| Unclassified | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | Class 3 | NIK |
| Unclassified | Defibrillator, Implantable, Dual-Chamber | Class 3 | MRM |
| Unclassified | Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode | Class 3 | OJX |
| Unclassified | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | Class 3 | NVN |
| Unclassified | Pacemaker/Icd/Crt Non-Implanted Components | Class 3 | OSR |
| Unclassified | Permanent Defibrillator Electrodes | Class 3 | NVY |
| Unclassified | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | Class 3 | NKE |
| Unclassified | Pulse Generator, Permanent, Implantable | Class 3 | NVZ |
| Unclassified | System, Pacing, Temporary, Acute, Internal Atrial Defibrillation | Class 3 | MTE |
| Unclassified | Wearable Automated External Defibrillator | Class 3 | MVK |
| §870.5310 | Automated External Defibrillators (Non-Wearable) | Class 3 | MKJ |
| §870.5310 | Over-The-Counter Automated External Defibrillator | Class 3 | NSA |
| §870.3720 | Tester, Pacemaker Electrode Function | Class 2 | DTA |
| Unclassified | Implantable Cardioverter Defibrillator (Non-Crt) | Class 3 | LWS |
| Unclassified | Implantable Pulse Generator, Pacemaker (Non-Crt) | Class 3 | LWP |
| Unclassified | Pulse-Generator, Single Chamber, Sensor Driven, Implantable | Class 3 | LWO |
| §870.3700 | Programmer, Pacemaker | Class 3 | KRG |
| Unclassified | Device, Removal, Pacemaker Electrode, Percutaneous | Class 3 | MFA |
| Unclassified | System, Esophageal Pacing | Class 3 | LPA |
| §870.3680 | Electrode, Pacemaker, Temporary | Class 2 | LDF |
| §870.3680 | Electrode, Pacing And Cardioversion, Temporary, Epicardial | Class 2 | NHW |
| §870.3680 | Permanent Pacemaker Electrode | Class 3 | DTB |
| §870.3630 | Analyzer, Pacemaker Generator Function | Class 2 | DTC |
| §870.3620 | Pacemaker Lead Adaptor | Class 2 | DTD |
| Unclassified | Pulse-Generator, Single Chamber, Single | Class 3 | LWW |
| §870.3610 | Implantable Pacemaker Pulse-Generator | Class 3 | DXY |
| §870.3600 | Pulse Generator, External Pacemaker, Dual Chamber | Class 2 | OVJ |
| §870.3600 | Pulse-Generator, Pacemaker, External | Class 3 | DTE |
| §870.1750 | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | Class 2 | JOQ |
| 21 CFR 801 Labeling, medical devices, reporting and recordkeeping requirements. | |||
| 21 CFR 809 Labeling, medical devices. | |||
| No relevant guidance developed at this time. |